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基线HIV耐药性与抗逆转录病毒治疗反应之间的关系:使用标准化数据分析计划对回顾性和前瞻性研究进行重新分析

The relation between baseline HIV drug resistance and response to antiretroviral therapy: re-analysis of retrospective and prospective studies using a standardized data analysis plan.

作者信息

DeGruttola V, Dix L, D'Aquila R, Holder D, Phillips A, Ait-Khaled M, Baxter J, Clevenbergh P, Hammer S, Harrigan R, Katzenstein D, Lanier R, Miller M, Para M, Yerly S, Zolopa A, Murray J, Patick A, Miller V, Castillo S, Pedneault L, Mellors J

机构信息

Harvard School of Public Health, Boston, Mass., USA.

出版信息

Antivir Ther. 2000 Mar;5(1):41-8. doi: 10.1177/135965350000500112.

DOI:10.1177/135965350000500112
PMID:10846592
Abstract

To assess the relation between resistance to antiretroviral drugs for treatment of HIV-1 infection and virological response to therapy, results from 12 different studies were re-analysed according to a standard data analysis plan. These studies included nine clinical trials and three observational cohorts. The primary end-point in our analyses was virological failure by week 24. Baseline factors that were investigated as predictors of virological failure were plasma HIV-1 RNA, the number and type of new antiretroviral drugs in the regimen, and viral susceptibility to the drugs in the regimen, determined by genotyping or phenotyping methods. These analyses confirmed the importance of both genotypic and phenotypic drug resistance as predictors of virological failure, whether these factors were analysed separately or adjusted for other baseline confounding factors. In most of the re-analysed studies, the odds of virological failure were reduced by about twofold for each additional drug in the regimen to which the patient's virus was sensitive by genotyping methods, and by about two- to threefold for each additional drug that was sensitive by phenotyping.

摘要

为评估抗逆转录病毒药物治疗HIV-1感染的耐药性与治疗的病毒学反应之间的关系,根据标准数据分析计划对12项不同研究的结果进行了重新分析。这些研究包括9项临床试验和3个观察性队列。我们分析的主要终点是第24周时的病毒学失败。作为病毒学失败预测指标进行研究的基线因素包括血浆HIV-1 RNA、治疗方案中新抗逆转录病毒药物的数量和类型,以及通过基因分型或表型分析方法确定的病毒对治疗方案中药物的敏感性。这些分析证实了基因型和表型耐药性作为病毒学失败预测指标的重要性,无论这些因素是单独分析还是针对其他基线混杂因素进行调整。在大多数重新分析的研究中,对于通过基因分型方法显示患者病毒敏感的治疗方案中每增加一种药物,病毒学失败的几率降低约两倍,对于通过表型分析显示敏感的每增加一种药物,病毒学失败的几率降低约两到三倍。

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